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ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program,audit team, communication with customers, and conflict resolution.CertificationAfter successfully passing the exam, you can apply for one of the following credentials with PECB. You will receive the certificate once you comply with all the requirements related to your selected credential.PECB Certified ISO 13485 Provisional AuditorPECB Certified ISO 13485 AuditorPECB Certified ISO 13485 Lead AuditorPECB Certified ISO 13485 Senior Lead AuditorPECB Certified ISO 13485 MasterEnrolment informationBy enrolling on this course you agree to your personal information being passed to PECB.Learners enrolling onto this course will receive an email from PECB to set up your Learner Account, course registration, access to the course materials and final exam.If you have not received this information within 5 working days please contact Global.PECB.Training@sgs.comGeneral informationPECB will provide training material of over 450 pages of information and practical examples.Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 16 CPD (Continuing Professional Development) credits.In case of exam failure, the candidate can retake the exam once for free within 12 months following the initial exam date.PrerequisitesA fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.The fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included)First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF) (AMF is not applicable for Foundation, Provisional and Transition Certification)

ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement.CertificationAfter successfully passing the exam, you can apply for the following credential with PECB. You will receive the certificate once you comply with all the requirements related to your selected credential.PECB Certificate Holder in ISO 13485 Foundation.Enrolment informationBy enrolling on this course you agree to your personal information being passed to PECB.Learners enrolling onto this course will receive an email from PECB to set up your Learner Account, course registration, access to the course materials and final exam.If you have not received this information within 5 working days please contact Global.PECB.Training@sgs.comGeneral informationPECB will provide training material of over 200 pages of information and practical examples.Learners may reach out to PECB to request the Attestation of Course Completion as proof of taking the course, this can be requested before taking the exam or after and is worth 7 CPD (Continuing Professional Development) credits.In case of exam failure, the candidate can retake the exam once for free within 12 months of the initial exam date.PrerequisitesThere are no prerequisites to participate in this training course.The fee for this course covers:Course Materials (for lifetime, please note that updated course materials are not included)First ExamOne resit exam (if required)PECB Certification FeeFirst Year PECB Annual Maintenance Fee (AMF) (AMF is not applicable for Foundation, Provisional and Transition Certification)

Learn about the requirements of a Work Permit System (WPS) to perform maintenance activities safely using a formal written safety control procedure that will assist in the prevention of accidents, injury to personnel, damage to plant/machinery, product, a client site or the environment.

This subject consists of 5 modules, which explore the rules and guidelines of the International Labour Organisation (ILO) and how this knowledge can contribute to improved health and safety programmes in our organisations 1.    The ILO and legal liability 2.    National Policies on Health and Safety  3.    Duties of employers and employees  4.    Workplace Health and Safety implementation  5.    Labour Inspectors 

Learn about the use of PPE and how it can reduce exposure to hazards and how assessing ergonomic risks can reduce the risk of injury/illness and enhance worker productivity.

This subject consists of 1 module, which explores the importance of regular workplace inspections as part of the overall occupational health and safety program.   Inspection process. 

This subject consists of 3 modules, which explore incident investigations. Overview of incident investigation.  Causes and consequences of incidents. Reporting and investigation of workplace incidents.

This subject consists of 2 modules, which explore the requirements related to the management and control of hazardous chemical substances in the workplace:  Overview of HCS   Management and control of HCS 

This subject consists of 2 modules, which explore hazard identification, workplace rules, risk assessment and implementing the relevant control measures.  Hazardous Work.   Conducting HIRA.